Peddie David, Small Serena S, Badke Katherin, Bailey Chantelle, Balka Ellen, Hohl Corinne M
Centre for Clinical Epidemiology and Evaluation, Vancouver Coastal Health Research Institute, Vancouver, BC, Canada.
School of Communication, Simon Fraser University, Burnaby, BC, Canada.
JMIR Med Inform. 2018 Jun 28;6(2):e10248. doi: 10.2196/10248.
Patients commonly transition between health care settings, requiring care providers to transfer medication utilization information. Yet, information sharing about adverse drug events (ADEs) remains nonstandardized.
The objective of our study was to describe a minimum required dataset for clinicians to document and communicate ADEs to support clinical decision making and improve patient safety.
We used mixed-methods analysis to design a minimum required dataset for ADE documentation and communication. First, we completed a systematic review of the existing ADE reporting systems. After synthesizing reporting concepts and data fields, we conducted fieldwork to inform the design of a preliminary reporting form. We presented this information to clinician end-user groups to establish a recommended dataset. Finally, we pilot-tested and refined the dataset in a paper-based format.
We evaluated a total of 1782 unique data fields identified in our systematic review that describe the reporter, patient, ADE, and suspect and concomitant drugs. Of these, clinicians requested that 26 data fields be integrated into the dataset. Avoiding the need to report information already available electronically, reliance on prospective rather than retrospective causality assessments, and omitting fields deemed irrelevant to clinical care were key considerations.
By attending to the information needs of clinicians, we developed a standardized dataset for adverse drug event reporting. This dataset can be used to support communication between care providers and integrated into electronic systems to improve patient safety. If anonymized, these standardized data may be used for enhanced pharmacovigilance and research activities.
患者通常会在不同的医疗环境之间转换，这就要求医疗服务提供者传递用药信息。然而，关于药物不良事件（ADEs）的信息共享仍未标准化。
我们研究的目的是描述一个临床医生记录和交流药物不良事件所需的最小数据集，以支持临床决策并提高患者安全性。
我们采用混合方法分析来设计一个记录和交流药物不良事件所需的最小数据集。首先，我们对现有的药物不良事件报告系统进行了系统综述。在综合报告概念和数据字段后，我们进行了实地调查，为初步报告表的设计提供信息。我们将这些信息展示给临床医生终端用户群体，以确定推荐的数据集。最后，我们以纸质形式对该数据集进行了试点测试和完善。
我们评估了在系统综述中识别出的总共1782个独特的数据字段，这些字段描述了报告者、患者、药物不良事件以及可疑和伴随药物。其中，临床医生要求将26个数据字段纳入数据集中。关键考虑因素包括避免报告已经以电子方式提供的信息、依赖前瞻性而非回顾性因果关系评估以及省略被认为与临床护理无关的字段。
通过关注临床医生的信息需求，我们开发了一个用于药物不良事件报告的标准化数据集。该数据集可用于支持医疗服务提供者之间的交流，并整合到电子系统中以提高患者安全性。如果进行匿名处理，这些标准化数据可用于加强药物警戒和研究活动。
